TRIENTINA 167 mg Kapsułka Twarda
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Treść ulotki
Trientina Tillomed 167 mg hard capsules
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Trientina Tillomed is and what it is used for
- 2. What you need to know before you take Trientina Tillomed
- 3. How to take Trientina Tillomed
- 4. Possible side effects
- 5. How to store Trientina Tillomed
- 6. Contents of the pack and other information
1. What is Trientina Tillomed and what is it used for
Trientina Tillomed contains trientine. This medicine is used for the treatment of Wilson's disease. Wilson's disease is a hereditary condition in which the body is unable to transport copper in the body normally or to remove it, as secretion from the liver to the intestine. This means that small amounts of copper from food and beverages accumulate until they reach excessive levels and can cause damage to the liver and problems with the nervous system. This medicine works mainly by binding to the copper present in the body, allowing its elimination through the urine and helping to lower copper levels. It can also bind to the copper present in the intestine, thereby reducing the amount absorbed by the body.
Trientina Tillomed is administered to adults, adolescents and children aged 5 years and over who do not tolerate another medicine indicated for the treatment of this disease, called penicillamine.
Controls the amount of copper present in the body by binding to it. Copper can then be eliminated from the body.
2. What you need to know before you take Trientina Tillomed
Do not take Trientina Tillomed:
- If you are allergic to trientine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Trientina Tillomed.
If you were already taking another medicine containing trientine, your doctor may adjust the dose
daily, the number of capsules or the number of administrations during the day when switching
to treatment with Trientina Tillomed.
Symptoms may worsen after starting treatment. If this happens, tell your doctor.
The doctor will regularly perform blood and urine tests to ensure that you receive the dose of
Trientina Tillomed most suitable for controlling symptoms and copper levels.
Tell your doctor if you experience any side effects, as this may indicate that the
dose of trientine needs to be increased or decreased.
This medicine can also reduce the level of iron in the blood and your doctor may prescribe iron
supplements (see section "Other medicines and Trientina Tillomed" below).
If you have kidney or liver problems, your doctor will regularly check that the treatment dose is
appropriate and does not affect the functioning of the kidneys or liver.
The combination of trientine with another medicine containing zinc is not recommended.
Reactions from lupus-like syndrome (symptoms may include persistent rash, fever, joint pain and fatigue) have been reported in some patients who switched to trientine after treatment
with penicillamine. However, it has not been possible to determine whether the reaction was due to trientine or
to previous treatment with penicillamine.
Children and adolescents
The doctor will perform more frequent checks to ensure that copper levels are maintained at a level
adequate for normal growth and mental development.
Other medicines and Trientina Tillomed
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
In particular, you should tell your doctor if you are already taking iron supplements or if you take remedies for
digestive disorders (medicines that reduce discomfort after meals). In this case, you may need to
take Trientina Tillomed at a different time of day to maintain its effectiveness.
If you take iron supplements, make sure at least two hours have passed between taking Trientina
Tillomed and taking the iron supplements.
Trientina Tillomed with food and drink
Swallow the capsules with water on an empty stomach, at least one hour before meals or two hours after meals and
at least one hour away from any other medicine, food or milk.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine. You and your doctor
must discuss the potential benefits of treatment thoroughly, while also considering any possible risks that continuing
therapy may entail. Your doctor will advise you on which treatment and which dose are most suitable for your situation.
If you are pregnant and taking Trientina Tillomed, you will be monitored throughout your pregnancy for
any effects on the baby or changes in your blood copper levels.
At the birth of the baby, the levels of copper and ceruloplasmin in the baby's blood will also be monitored.
It is not known whether trientine passes into breast milk. It is important to tell your doctor if
you are breastfeeding or intend to breastfeed. The doctor will help you decide whether to
stop breastfeeding or stop taking Trientina Tillomed, considering the benefits of breastfeeding for the baby and the benefit of therapy with Trientina
Tillomed for the mother. The doctor will decide on the treatment and the dose most appropriate for your situation.
Driving and using machines
It is not believed that trientine affects the ability to drive vehicles or use tools or machinery.
Trientina Tillomed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially "sodium-free".
3. How to take Trientina Tillomed
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
In adults of all ages, including the elderly, the recommended total daily dose is between 4
and 8 capsules per day (for a total of 670-1340 mg of trientine base), to be taken orally. This
total daily dose will be divided into 2 or 4 smaller doses to be taken throughout the day. Your
doctor will inform you how many capsules you need to take and how often per day.
Use in children
The dose to be taken is generally lower than that for adults and depends on age and body
weight. The total daily dose is between 2 and 5 capsules (330-840 mg of trientine base), to
be taken orally. This total daily dose will be divided into 2 or 4 smaller doses to be taken
throughout the day. Your doctor will inform you how many capsules you need to take and how often
per day.
Once treatment has started, your doctor may adjust the dose based on the response to treatment.
Swallow the capsules with water on an empty stomach, at least one hour before meals or two hours after meals and
at least one hour apart from other medicines, food or milk.
If you are taking iron supplements, take them at least two hours after the dose of Trientina Tillomed.
If you take more Trientina Tillomed than you should
Take Trientina Tillomed only if it has been prescribed to you. If you think you have taken more Trientina Tillomed than
you were told, contact your doctor or pharmacist.
If you forget to take Trientina Tillomed
If you forget to take one or more doses, take another dose as soon as possible, then take the next
dose according to the scheduled time. Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Occasionally, treatment with trientina may cause inflammation of the small intestine
or colon. If you experience any of the following side effects, contact your doctor immediately.
The following side effects have been reported:
Common (may affect up to 1 in 10 people)
- feeling unwell (nausea)
Uncommon (may affect up to 1 in 100 people)
- skin rashes
- itching
- anemia
Not known (frequency cannot be estimated from available data)
- stomach discomfort and disturbances, including severe stomach pain (duodenitis)
- inflammation of the intestine which can cause, for example, abdominal pain, recurrent diarrhea and blood in the stools (colitis)
- decrease in the number of red blood cells due to low iron levels in the blood (iron deficiency anemia)
- urticaria
If you suffer from Wilson's disease, you should inform your doctor if you experience the following symptoms:
worsening of the nervous system (e.g. tremors, lack of coordination, speech disorders, muscle
rigidity, worsening of muscle spasms)
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
help to provide more information on the safety of this medicine.
5. How to store Trientina Tillomed
Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature. Keep the bottle tightly
closed to protect the medicine from humidity.
Do not use this medicine after the expiry date which is reported on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Trientina Tillomed contains
The active ingredient is trientine. Each hard capsule contains 250 mg of trientine dihydrochloride equivalent
to 167 mg of trientine.
The other ingredients are:
Capsule content: anhydrous colloidal silica (E551), stearic acid.
Capsule shell: gelatin, sodium lauryl sulfate, red iron oxide (E172), yellow iron oxide
(E172), titanium dioxide (E171), printing ink: shellac (E904), propylene glycol
(E1520), potassium hydroxide (E525), black iron oxide (E172).
Description of the appearance of Trientina Tillomed and contents of the pack
Hard gelatin capsule of opaque brown color, size 1, with "HP551" imprinted in black
ink on the capsule body and cap. The capsule length is between 18.9 mm and
19.7 mm.
Trientina Tillomed capsules are available in opaque white HDPE bottles with child-resistant PP
closure.
Pack size: 100 hard capsules
Trientina Tillomed capsules are also available in Al-Al blisters.
Pack sizes: 30, 72, 96, 100, 240 and 300 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale G. Richard, 1 Torre A
20143 Milan (MI), Italy
Manufacturer
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta
SGS Pharma Magyarorszag Kft.
Derkovits Gyula Utca 53,
Budapest XIX,1193,
Hungary
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Cuivrin 167 mg Hard Capsules
Belgium: Trientine Tillomed 167 mg capsules
Triëntine Tillomed 167 mg hard capsules
Trientin Tillomed 167 mg Hard Capsules
France: Trientine Tillomed 167 mg, capsules
Germany: Trientin Tillomed 167 mg Hard Capsules
Greece: Trientine/Tillomed 167 mg σκληρό καψάκιο
Ireland: Trientine 167 mg hard capsules
Italy: Trientina Tillomed
Luxembourg: Trientine Tillomed 167 mg, capsules
Norway: Trientine Tillomed Pharma GmbH
Netherlands: Triëntine Tillomed 167 mg hard capsules
Czech Republic: Trientine Tillomed 167 mg tvrdé tobolky
Slovakia: Trientine Tillomed 167 mg tvrdé kapsuly
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 167 MG
- Kod ATCA16AX12
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TRIENTINA TILLOMEDPostać farmaceutyczna: Hard capsule, 200 MGSubstancja czynna: trientineProducent: UNIVAR SOLUTION BVWymaga receptyPostać farmaceutyczna: Tablet, 500 MGSubstancja czynna: sodium phenylbutyrateProducent: IMMEDICA PHARMA ABBez recepty
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TRIENTINA TILLOMED wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w TRIENTINA TILLOMED jest trientine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
TRIENTINA TILLOMED jest produkowany przez TILLOMED ITALIA SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie TRIENTINA TILLOMED jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić TRIENTINA TILLOMED w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (trientine) to m.in. KUFENKE, KUPRIOR, AMMONAPS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
